On June 27, 2025, the National Class I Biopharmaceutical "Tetanus Shot" Sintetol (generic name: Siltartoxatug Injection), independently developed by Zhuhai Trinomab Pharmaceutical Co., Ltd. (hereinafter referred to as "Trinomab"), was included in the "Guangdong Innovative Medical Products Catalog" (First Batch). As a breakthrough in tetanus prevention and treatment, this achievement lays a solid foundation for accelerating clinical applications across Guangdong Province and nationwide, benefiting more patients.
Policy Support: A Triple Mechanism to Break through Market Access and Payment Barriers
Enhancing Inpatient Adoption
Public medical institutions shall hold pharmaceutical and medical device committee meetings quarterly (or as needed), strictly adhering to the principle of "comprehensive inclusion" to incorporate products into the hospital formulary.
Private and foreign-funded medical institutions are encouraged to adopt similar practices to promote the application of medical prroducts in the province in accordance with the law.
Commercial Insurance Integration
Facilitate data connectivity between medical institutions and commercial insurance companiesto optimize "one-stop" settlement for basic medical insurance, critical illness insurance, and medical assistance, thereby accelerating access to innovative products.
Comprehensive Promotion Framework
Hosting national-level industry events such as the China Bioindustry Conference to elevate the profile of local drugs and medical devices.
Conducting the "100 Enterprises & 100 Hospitals Guangdong Medical Tour" to foster hospital-enterprise collaboration and accelerate adoption of innovative drugs and devices.
Clinical Pain Points: The "Broken Window Effect" of Traditional Prevention and Immune Blind Spots
Tetanus is an acute, life-threatening disease with approximately one million cases reported globally each year[1]. Without medical intervention, the fatality rate approaches 100%, and even with intensive care, mortality remains 30–50%[1]. Clostridium tetani is widely present in soil, dust, and animal feces. Once entering the human body through wounds, it can cause severe infections. Therefore, timely and effective prevention is critical.
The incubation period of tetanus is like a "biological time mystery box"—ranging from 24 hours to several months. The moment symptoms appear is entirely up to the bacteria's "random selection," with shorter incubation correlating to worse outcomes. Approximately 10% of cases have an incubation period shorter than 48 hours[2], and can be as short as 24 hours (e.g., in head, face, or neck injuries with severe contamination), during which bacteria rapidly multiply and release toxins in oxygen-deprived environments. Meanwhile, 3% of cases exhibit an incubation period exceeding 30 days[2], occasionally lasting several months (e.g., when anaerobic conditions develop due to tissue necrosis after wound healing). Such patients often neglect follow-up prevention measures, assuming the "wound has already healed."
Traditional "tetanus shots" fail to fully cover both disease incubation periods, with TAT offering protection for only up to 10 days and HTIG for 28 days. Additionally, HTIG requires 48 hours to take effect. In cases of contaminated wound exposure, the condition often progresses rapidly, posing majort challenges for tetanus prophylaxis. The cost of tetanus treatment is extremely high. Studies show the median hospitalization expense for severe tetanus cases reaches 136,870 yuan (33,570~210,987 yuan)[3]. Critical patients often require ICU care, resulting in significant financial burdens and health risks.
Breakthrough Solution: Gene Recombination Technology Rewrites Prevention Rules
Sintetol, as a globally leading monoclonal antibody biologic developed through gene recombination technology, has achieved a groundbreaking breakthrough by eliminating reliance on "human blood" or "horse blood" as raw materials. It fundamentally transforms the traditional prevention and treatment model of "tetanus shots."
Seizing the Latent Window Period
Sintetol achieves rapid onset within 12 hours after administration, with 95.4% of patients reaching protective levels. Compared to traditional "tetanus shots," Sintetol, a new industry standard with significantly faster onset and longer-lasting protection—maintaining median protective antibody levels for up to 132 days. Its neutralizing antibody titer is 5-7 times higher than that of HTIG. These advantages are collectively referred to as the "Three Superiorities" theory: faster onset, higher antibody titer, and longer-lasting antibody levels, greatly reducing the risk of infection.
Single-dose administration:
Sintetol demonstrates excellent safety profile. No skin test is required, no routine outpatient observation is needed, and no dose adjustment is necessary based on body weight or wound size. The administration process is simplified from the traditional complex model of "skin test + multiple observations + dose adjustments" to a "one-shot solution." The fixed-dose design for all populations eliminates dosage errors caused by weight/injury severity. Meanwhile, it effectively eliminates the time-consuming desensitization process required for Tetanus Antitoxin (TAT) injections and avoids the potential risk of anaphylactic shock!
Under the guidance of Guangdong Province's Innovative Drug Action Plan, Sintetol leverages the policy "fast track" to accelerate its adoption in Guangdong's medical institutions, setting a model and driving force for nationwide promotion of innovative drugs, thereby boosting momentum of pharmaceutical innovation.
Reference:
[1]Diagnosis and Treatment Guidelines for Non-Neonatal Tetanus (2024 Edition). General Office of the National Health Commission, 2024.
[2]StanleyA. Plotkin, Walter A. Orenstein, Paul A. Offit, et al. Plotkin‘s Vaccines (Seventh Edition): 58 - Tetanus Toxoid. Elsevier, 2018, Pages 1052-1079.e18.
[3]《Trends and Hospitalization Outcomes of Tetanus Cases: A Multicenter Retrospective Study in Suzhou, 2013–2023》
(Sintetol Trademark Registration No.: Class 5-74174546)
